The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Amendment To Angiography Kit W/addit.
| Device ID | K842113 |
| 510k Number | K842113 |
| Device Name: | AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MALLINCKRODT CRITICAL CARE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-19 |
| Decision Date | 1984-07-13 |